Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Public ClinicalTrials.gov record NCT00388674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
Study identification
- NCT ID
- NCT00388674
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 12,522 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2006 (Actual)
- Primary completion
- Oct 26, 2016 (Actual)
- Completion
- Oct 26, 2016 (Actual)
- Last update posted
- Jul 30, 2018
2006 – 2016
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scti Research Foundation | Coronado | California | 92118 | — |
| Cedars-Sinai Comprehensive Transplant Center | Los Angeles | California | 90048 | — |
| Kaiser Permanente Medical Center | San Francisco | California | 94118 | — |
| University Of Connecticut Health Center | Farmington | Connecticut | 06030-1845 | — |
| University Of Miami Center For Liver Diseases | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | — |
| Rush University Med Ctr | Chicago | Illinois | 60612 | — |
| Indiana University | Indianapolis | Indiana | 46202-5121 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Medical Procare, Pllc | Flushing | New York | 11355 | — |
| Office Of Sing Chan Md | Flushing | New York | 11355 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Va New York Harbor Healthcare System | New York | New York | 10010 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112-4481 | — |
| Phgi Associates, Ltd | Philadelphia | Pennsylvania | 19106 | — |
| Thomas Jefferson Medical College | Philadelphia | Pennsylvania | 19107 | — |
| Upmc Center For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| UT Southwestern Medical Center | Dallas | Texas | 7390-8887 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 270 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00388674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2018 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00388674 live on ClinicalTrials.gov.